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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02804243
Other study ID # 27-10
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date May 2018

Study information

Verified date September 2017
Source National Hospital Organization Minami Kyoto Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.


Description:

In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. Oxygen supplementation during exercise induced dose-dependent improvement in endurance and symptom perception in chronic obstructive pulmonary disease patients. Recently, nasal high flow therapy which consists of high flow gas with an FiO2 ranging from 0.21 to nearly 1.0 adjusted by an oxygen blender, brought to body temperature, and saturated with water through an in-line humidifier is available.

The present study is randomised to compare the effect of exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months.

Exclusion Criteria:

- Subjects with severe cardiovascular disease, diabetes, neurological disease, and renal failure.

- Subject who are unable to undergo rehabilitation.

Study Design


Intervention

Device:
nasal high flow therapy
The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.

Locations

Country Name City State
Japan National Hospital Organization Minami Kyoto Hospital Joyo Kyoto

Sponsors (1)

Lead Sponsor Collaborator
National Hospital Organization Minami Kyoto Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Walk distance (measured by six minutes walking test) Four weeks
Secondary Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.) Four weeks
Secondary Exercise tolerance test (exercise time et.) Four weeks
Secondary Body composition measured by InBody (muscle mass et.) Four weeks
Secondary Arterial blood gas Four weeks
Secondary Inflammation (CRP et.) Four weeks
Secondary Nutritional status (body mass index(kg/m2) et.) Four weeks
Secondary Sympathetic activity (Catecholamine et.) Four weeks
Secondary Dyspnea (Modified Borg scale) Four weeks
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